A clinical study of the tolerance and safety of a beta-propiolactone-treated immunoglobulin.
In an open clinical study, 31 healthy volunteers were each given three i.v. infusions of 50 ml of a immunoglobulin preparation (Intraglobin) from three different production batches. During a 35-week observation period every three weeks blood specimens were drawn from the participants and analysed for serological (HBsAg, anti-HBs, anti-HBc, HBeAg and anti-HBe) and clinico-chemical parameters of hepatitis (SGOT, SGPT, gamma-GT and bilirubin levels). In no case evidence of the development of hepatitis arose, nor did the participants suffer from any side-effects during or after the infusions. Ten out of the 31 subjects then received another 150 ml infusion followed by an intradermal application of the new immunoglobulin in a 1:10 dilution four weeks later. No signs of immediate or delayed hypersensitivity reactions could be observed in the volunteers.
D000410:Alanine Transaminase / Q000097:blood; D001219:Aspartate Aminotransferases / Q000097:blood; D006510:Hepatitis B Antibodies / Q000032:analysis; D006511:Hepatitis B Antigens / Q000032:analysis; D006514:Hepatitis B Surface Antigens / Q000032:analysis; D006801:Humans; D007074:Immunoglobulin G / Q000031:analogs & derivatives* / Q000633:toxicity; D016756:Immunoglobulins, Intravenous; D011420:Propiolactone; D013997:Time Factors
D006510:Hepatitis B Antibodies; D006511:Hepatitis B Antigens; D006514:Hepatitis B Surface Antigens; D007074:Immunoglobulin G; D016756:Immunoglobulins, Intravenous; D011420:Propiolactone; D001219:Aspartate Aminotransferases; D000410:Alanine Transaminase